New Products and Industry News

Patent infringement dispute settled 

Hydrofera, LLC (Willimantic, CT) and EXURO Medical, LLC (Salt Lake City, UT) reached a settlement following the United States Patent Office’s recent decision that asserted US Patent No. 6,183,764, as amended, is valid and the Hydrofera, LLC’s lawsuit in the US Federal Court for the District of Utah alleging infringement of this patent by EXURO Medical, LLC and GWM Products, LLC (now known as Keneric Healthcare) can resume. Under the terms of the settlement, EXURO Medical will refrain from distributing certain wound dressings offered by GWM Products, LLC alleged to infringe this patent and will continue to refrain from doing so for the duration of the patent term. In exchange, Hydrofera, LLC has agreed to dismiss EXURO Medical from the lawsuit.  Further details of the settlement are not being made available. 

CMS gives biodynamic therapy system Ambulatory Patient Classification

Nuo Therapeutics, Inc. (Gaithersburg, MD) announced the Aurix™ System reimbursement rate under the Hospital Outpatient Prospective Payment System for the calendar year 2016 has been published by the Centers for Medicare and Medicaid Services. Aurix was placed in Ambulatory Payment Classification 5054 (Level 4 Skin Procedures) and will be reimbursed at a national average rate of $1,411 per application effective January 1, 2016.

For more information, visit: www.nuot.com. 

Biotherapeutic product receives marketing approval

Organogenesis Inc (Canton, MA/Reinach, Switzerland) announced its Apligraf® wound-healing technology has become the first transplant product in Switzerland to receive marketing authorization from Swissmedic (Berne, Switzerland) for the treatment of venous leg ulcers (VLU) and diabetic foot ulcers (DFU). In Switzerland, the classification of “transplant products” includes cell therapies such as this product.

With marketing approval of this product, Switzerland has become the first country in Europe to grant marketing authorization for a bioengineered transplant product. Swissmedic applies a rigorous, pharmaceutical-like premarket regulatory review process to the approval of transplant products.  The Swissmedic approval is another validation by a leading regulatory agency of the safety and efficacy of this product, which is already FDA-approved in the United States for the treatment of VLUs and DFUs. The company’s products have regulatory approval in United States, Canada, Mexico, Saudi Arabia, Kuwait, South Africa, Singapore, and Switzerland.

This product is a biotherapeutic wound-healing technology that contains 2 layers of human living cells: a layer of differentiated keratinocytes and a layer of fibroblasts in a collagen matrix. When placed on a chronic wound previously unresponsive to treatment, the product provides cells, collagen matrix, and other bioactive proteins and has been demonstrated to effectively and safely promote healing, superior to conventional treatments alone. A recent study found patients using this product had a 28% lower amputation rate, 33% fewer days hospitalized, and 32% fewer emergency department visits than their respective matched controls.

For more information, visit www.organogenesis.com. 

System manages smaller incisions, anatomically challenging areas

 Acelity (San Antonio, TX) extended its Prevena™ Therapy portfolio with the addition of a new, shorter Peel & Place™ System. The dressing in the Peel & Place™ - 13 System is identical to the existing system except for its shorter length; it is designed for the management of linear incisions up to 13 cm. The new system is available in the United States and Europe, and expanded availability globally is anticipated in January 2016.

This expansion of the Prevena™ Peel & Place™ product line enables a surgeon to target negative pressure therapy for incisions in anatomically challenging areas of the body. The new 13-cm dressing is provided either separately or in combination with the portable Prevena™ 125 Therapy Unit that provides negative pressure therapy in a small, easy-to-operate device that can transition home with the patient. This system will make Prevena™ Therapy available for a wider range of incisions.

For more information, visit: www.acelity.com. 

Ostomy mobile application launched

11 Health (London, England) launched its Ostom-I Alert, a connected device and mobile application to monitor ostomy pouch output. The Ostom-i Alert sensor is a discrete innovative device that alerts patients as to how full their ostomy pouches are so they can decide when to empty them. The device clips on to any ostomy pouch, sending Bluetooth® alerts to a mobile phone or tablet app telling the user his/her pouch is filling up. The mobile app is available for iPhone and Android smartphone users. Physicians can also remotely monitor their patients.

For more information, visit: www.11health.com. 

Medical device heals burns

Avita Medical Ltd. (Northridge, CA and Cambridge, United Kingdom) announced the publication of 3 academic papers that further demonstrate ReCell®’s effectiveness for triggering healing in burns and helping with scar revision and repigmentation. The papers were presented at the 16th European Burns Association (EBA) Congress in Hannover, Germany. The proceedings of the Congress appeared in a September 2015 supplement to the Annals of Burns and Fire Disasters.

For more information, visit: www.avitamedical.com. 

OAB device approved for trial

StimGuard (Ft. Lauderdale, FL) received US Food and Drug Administration approval to conduct a clinical trial of a percutaneously implantable device for treating urgency urinary incontinence caused by overactive bladder (OAB) syndrome. Utilizing wireless technology, the device is placed through a needle at the tibial nerve to activate the neural urinary pathways. The clinical trial will launch this winter and will evaluate the effectiveness of delivering pulsed electrical energy to surrounding tibial nerves that prompt the sacral nerves to regulate the bladder.

For more information, visit: www.biospace.com/News/stimguard-release-fda-grants-chronic-tibial-nerve/394398. 

Pneumatic compression excels for lymphedema patients

A recent study published in the Journal of the American Medical Association (JAMA) Dermatology demonstrated use of an advanced pneumatic compression device, the Flexitouch® System (Tactile Medical, Minneapolis, MN), significantly benefited patients with lymphedema by reducing key adverse clinical events and health care costs. The study evaluated the impact of a lymphedema treatment on health outcomes and cost of care. The authors analyzed 718 lymphedema patients from across the United States over a 5-year period (2007–2013) from a large national administrative database and evaluated clinical events and costs for a 12-month period before and a 12-month period during treatment.

The Flexitouch System, a treatment used by patients at home, inflates over swollen areas of the limb or trunk to facilitate the movement of excess fluid out of the affected areas. After using the system, lymphedema patients demonstrated significant reductions in episodes of cellulitis, a form of skin infection common to lymphedema patients. From this large data source, the authors evaluated clinical events and costs in 2 patient subgroups, those with and without cancer-related lymphedema.  Patients in each group experienced a 79% and 75% reduction in the rate of cellulitis episodes, respectively.

For more information, visit: TactileMedical.com. 

New perforation capability launched

Scapa Healthcare launched its new perforation capability for Scapa Soft-Pro® Silicone Gel adhesives. The new capability allows Scapa Healthcare to offer its strategic business partners an expansive range of skin friendly turnkey solutions for the advanced wound care market.

Scapa Soft-Pro® Silicone Gel is a low-trauma adhesive that allows for easy application, removal, and reapplication on the same area. Its gentle skin friendly properties are ideal for users with fragile and sensitive skin. The new perforation capability meets dressing challenges for exudate management in the advanced wound care market.

For more information, please visit: www.scapahealthcare.com/.

Comparative effectiveness analysis published

A real-world comparative effectiveness analysis reported Apligraf® (Organogenesis, Inc, Canton, MA) demonstrated improved outcomes over Epifix (MiMedx Group, Inc, Marietta, GA) by a wide margin. The large-scale analysis, the first of its kind, examined healing rates of patients with diabetic foot ulcers who were treated with one of the products. Researchers found diabetic foot ulcers treated with Apligraf had significantly higher rates of healing in significantly less time compared to those treated with Epifix, increasing the probability of healing by 97%. These results indicate cost savings with Apligraf based on application frequency and faster time to healing.

For more information, please visit: www.organogenesis.com. 

Lymphedema company acquired

BSN Medical (Hamburg, Germany) acquired Seattle, WA-based JoViPak, a manufacturer of lymphedema garments. The addition of JoViPak diversifies BSN’s existing portfolio of products designed for the management of lymphatic disorders. The purchase follows the recent acquisition of FarrowMed, which provided BSN with the patented FarrowWrap compression wrap used to manage lymphedema.

For more information, please visit: www.bsnmedical.com/bsn-medical-global/press/press.html 

LIFE solution accelerates chronic wound healing

Researchers at the Loyola Institute of Frontier Energy (LIFE), Loyola College, developed a possible solution to accelerate the healing of chronic wounds by using fortified components of the placenta. In contrast to most nonfatal acute wounds that heal naturally or on medical intervention, the chronic wounds of pathological (diabetic, venous, neuropathic, and pressure ulcers) and infection (tropical ulcers) origins persist for long periods of time without showing any tendency to heal.

The research initiative led by Dr. S. Vincent, Director, LIFE, Loyola College, Chennai, and his associate scientist Dr. S. Sivasubramanian, developed fortified placental scaffolds capable of inducing rapid healing of chronic wounds by enhancing the therapeutic value of placental components such as amnion and chorion.

For more information, please visit: www.thehindu.com. 

Distribution agreement reached for wound care products

Vomaris Innovations (Tempe, AZ) reached a distribution agreement for its microcurrent-generating wound care products, Procellera antimicrobial wound dressings for the long-term care market, with Metrex (Orange, CA). Under the agreement, Metrex, which focuses on solutions to address cross-contamination within health care facilities, will have exclusive global distribution rights to Procellera technology in the long-term care market, while Procellera will continue manufacturing and research and development.

For more information, please visit:www.procellera.com. 

Laboratory study results announced at the SAWC

Kerecis (Iceland) presented laboratory results demonstrating that significantly more cells proliferate into acellular fish skin than a placenta-derived product on the market at the Symposium on Advanced Wound Care, held in September. These findings are the results of research done at the Center for System Biology at the University of Iceland.

For more information, please visit: https://news.sys-con.com/node/3474702 

European patent validated in 11 countries

One of Avita Medical’s (Northridge, CA) European patents has been validated in 11 countries: Austria, Belgium, France, Germany, Great Britain, Italy, the Netherlands, Portugal, Spain, Sweden and Turkey. The patent covers the broad use of the company’s cell suspension preparation device, ReCell®, and relates to a simple, rapid, and cost-effective technique for grafting cells, and in particular for preparing a suspension of cells using a tissue sample obtained from a donor site.

For more information, please visit:www.avitamedical.com.